Chronic RhinosinusitisPhase 3NCT02106793
Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis
A Phase 3 study testing Mitomicin C in people with Chronic Rhinosinusitis and Postoperative Nasal Synerchia, run by Mahidol University at 1 site in Thailand.
Trial summary
Primary objective To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery To validate the Thai version of disease-specific quality of life tool SNOT-22 Secondary objectives To compare the clinical signs and symptoms of CRS in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis, Postoperative Nasal Synerchia
- What is being tested?
- Mitomicin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2015to 1 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for CRS
- Patients must not have following diseases or conditions
- Cystic fibrosis based on positive sweat test or DNA test
- Gross immunodeficiency (congenital or acquired)
- Congenital mucociliary problem (eg. Primary ciliary dyskinesia)
- Altered immune function such as patients with systemic vasculitis, systemic lupus erythematosus, end stage renal disease, cirrhosis, currently taking immunosuppressant or granulomatous disease
- Severe comorbidity with life expectancy of less than 1 year, such as advanced stage malignancy patient, or severe infection
- Patients are willing to participate and provide written informed consent
Who cannot join
- (None)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis
Primary objective
- To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
- To validate the Thai version of disease-specific quality of life tool SNOT-22
Secondary objectives
- To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
- To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
- To compare the side effects of Mitomicin C versus placebo
- Being tested
- Mitomicin C, Identical placebo solution
- Keywords
- Chronic Rhinosinusitis, Mitomicin C, Postoperative nasal synerchia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomicin CDrug
Also called Mitomycin C
Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side.
Identical placebo solutionDrug
Identical placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Mitomicin C | Experimental | Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side. Receives: Drug: Mitomicin C |
| Placebo | Placebo comparator | Identical placebo solution Receives: Drug: Identical placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Synerchia
The primary outcome of interest is time to event, with the event as the occurrence of nasal synechia. The date of surgery will be used as the beginning date, and the last date will be the date that patient was defined as synechia, or the end of the study period if that patient does not have synechia on follow up.
Measured: 1 year
Secondary outcomes (3)
Scoring of SNOT-22
Scoring of translated SNOT-22 disease-specific quality of life measurement
Measured: 1 year
Clinical Symptom Score
Clinical symptom score of patients, measured by visual analog score which will be given by research nurse for a patient to fill in at baseline, 1 week, 1, 3, and 6 months.
Measured: 6 months
SNOT-22
Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pawin Numthavaj, M.D., Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106793
- Sponsor's protocol ID
- MitomicinC_PostopESS
- Status last verified
- May 2018
- First submitted
- 4 Apr 2014
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT02106793
- Acronym / sponsor ID
- MitomicinC_PostopESS
- Keywords
- Chronic Rhinosinusitis, Mitomicin C, Postoperative nasal synerchia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective
- To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
- To validate the Thai version of disease-specific quality of life tool SNOT-22
Secondary objectives
- To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
- To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
- To compare the side effects of Mitomicin C versus placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomicin C | Experimental | Drug: Mitomicin CMitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side. |
| Placebo | Placebo comparator | Drug: Identical placebo solutionIdentical placebo solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All Thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for CRS
- Patients must not have following diseases or conditions
- Patients are willing to participate and provide written informed consent
Key exclusion criteria (1 listed)
- (None)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomicin CAlso: Mitomycin CMitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side. | Drug | Mitomicin C |
| Identical placebo solutionIdentical placebo solution | Drug | Placebo |
Primary outcome
Postoperative Synerchia
Time frame: 1 year
The primary outcome of interest is time to event, with the event as the occurrence of nasal synechia. The date of surgery will be used as the beginning date, and the last date will be the date that patient was defined as synechia, or the end of the study period if that patient does not have synechia on follow up.
3 secondary outcomes
Scoring of SNOT-22
Time frame: 1 year
Clinical Symptom Score
Time frame: 6 months
SNOT-22
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawin Numthavaj, M.D. principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitomicin C in people with Chronic Rhinosinusitis and Postoperative Nasal Synerchia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Synerchia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.